1099721
Corporativo Serysi, S. De R.L. De C.V. — FEI 3012097599
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 16, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Zapopan (Mexico)
Citations
| ID | CFR | Description |
|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1796 | 21 CFR 211.80(d) | Identification of Each Lot in Each Shipment |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |